Administrative Code

Virginia Administrative Code
8/18/2022

Article 9. Photon Emitting Remote Afterloader Units, Teletherapy Units, and Stereotactic Radiosurgery Units

12VAC5-481-2040. Training requirements and use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

A. Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of a sealed source in remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units to be a physician:

1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state and who meets the requirements in subdivision 4 of this section. The names of board certifications that have been recognized by the agency, NRC, or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:

a. Successfully complete a minimum of three years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association; and

b. Pass an examination administered by diplomates of the specialty board that tests knowledge and competence radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy; or

2. Who has:

a. Completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

(1) 200 hours of classroom and laboratory training in the following areas: radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; and radiation biology; and

(2) 500 hours of work experience, under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements at a medical institution that is authorized for subsections B and C of this section, involving: reviewing full calibration measurements and periodic spot-checks; preparing treatment plans and calculating treatment doses and times; using administrative controls to prevent a medical event involving the use of radioactive material; implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console; checking and using survey meters; and selecting the proper dose and knowing how it is to be administered; and

b. Completed three years of supervised clinical experience in radiation therapy under an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another Agreement state requirements as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by this subdivision.

3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in subdivisions 2 a, 2 b, and 4 of this subsection and has achieved a level of competency sufficient to function independently as an AU of each type of therapeutic medical unit for which the individual is requesting AU status. The written attestation shall be signed by either:

a. A preceptor AU who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements for an AU for each type of therapeutic medical unit for which the individual is requesting AU status; or

b. A residency program director who affirms in writing that the attestation of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements for the type of therapeutic medical unit for which the individual is requesting authorized user status and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subdivisions 2 a and 2 b of this subsection.

4. Who has received training in device operation, safety procedures, and clinical use for the types of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an AU or authorized medical physicist, as appropriate, who is authorized for the types of use for which the individual is seeking authorization.

B. Licensees shall use sealed sources in photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:

1. As approved in the Sealed Source and Device Registry; or

2. In research in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

C. Licensees shall use photon-emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units:

1. As approved in the Sealed Source and Device Registry to deliver a therapeutic dose for medical use. These devices may be used for therapeutic medical treatments that are not explicitly provided for in the Sealed Source and Device Registry but must be used in accordance with radiation safety conditions and limitations described in the Sealed Source and Device Registry; or

2. In research in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016; Volume 37, Issue 25, eff. January 14, 2022; Errata, 38:10 VA.R. 902 January 3, 2022.

12VAC5-481-2041. Surveys required.

A. Radiation surveys.

1. In addition to the survey requirements in 12VAC5-481-750, licensees shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry.

2. The licensee shall make the survey required by subdivision 1 of this subsection at installation of a new source and following repairs to the source shielding, the source driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the unit or the source.

B. Patient surveys. Before releasing a patient or human research subject from licensee control, a licensee shall survey the patient or human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source has been removed from the patient or human research subject and returned to the safe shielded position.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 24, 2016.

12VAC5-481-2042. Installation, maintenance, adjustment, and repair.

A. Only a person specifically licensed by the agency, the NRC, or another agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source driving unit, or other electronic or mechanical components that could expose the source, reduce the shielding around the source, or compromise the radiation safety of the unit or the source.

B. Except for low dose-rate remove afterloader unit, only a person specifically licensed by the agency, the NRC, or another agreement state shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

C. For a low dose-rate remote afterloader unit, only a person specifically licensed by the agency, the NRC, or another agreement state or an authorized medical physicist shall install, replace, relocate, or remove a sealed source contained in the unit.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2043. Safety procedures and instructions, and precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

A. Safety procedures and instructions.

1. Licensees shall:

a. Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

b. Permit only individuals approved by the authorized user (AU), the authorized medical physicist (AMP), or the RSO to be present in the treatment room during treatment with sources;

c. Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

d. Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position, or remove the patient or human research subject from the radiation field with controls from the outside the treatment room. These procedures shall include:

(1) Instructions for responding to equipment failure and the names of the individuals responsible for implementing corrective actions;

(2) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

(3) The names and telephone numbers of the authorized user (AU), the authorized medical physicist (AMP), and the RSO to be contacted if the unit or the console operates abnormally.

2. A copy of the procedures required by subdivision 1 d of this subsection shall be physically located at the unit console.

3. Licensees shall post instructions at the unit console to inform the operator of:

a. The location of the procedures required by subdivision 1 d of this subsection; and

b. The names and telephone numbers of the AU, the AMP, and the RSO to be contacted if the unit or console operates abnormally.

4. Safety instruction and training.

a. Prior to the first use of patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit, a licensee shall ensure that vendor operational and safety training is provided to all individuals who will operate the unit. The vendor operational and safety training must be provided by the device manufacturer or by an individual certified by the device manufacturer to provide the operational and safety training.

b. Licensees shall provide instruction initially and at least annually to all individuals who operate the unit, as appropriate to the individual's assigned duties, in the procedures identified in subdivision 1 d of this subsection and the operating procedures for the unit.

5. Licensees shall ensure that operators, authorized users, and authorized medical physicists participate in drills of the emergency procedures initially and at least annually and document the exercise.

6. Licensees shall retain a record of individuals receiving instruction required by subdivision 4 of this subsection in accordance with 12VAC5-481-2070 L.

7. Licensees shall retain a copy of the procedures required by subdivisions 1 d and 4 b of this subsection in accordance with 12VAC5-481-2070 R.

B. Safety procedures for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

1. Licensees shall control access to the treatment room by a door at each entrance.

2. Licensees shall equip each entrance to the treatment room with an electrical interlock system that will:

a. Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

b. Cause the source to be shielded when an entrance door is opened; and

c. Prevent the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off console is reset at the console.

3. Licensees shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

4. Except for low-dose remote afterloader units, licensees shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

5. For licensed activities where sources are placed within the patient's or human research subject's body, licensees shall only conduct treatments that allow for expeditious removal of a decoupled or jammed source.

6. In addition to the requirements specified in subdivisions 1 through 5 of this subsection, licensees shall:

a. For medium dose-rate and pulsed dose-rate remote afterloader units, require:

(1) An AMP and either an AU or an physician under the supervision of an AU who has been trained to the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the units; and

(2) An AMP and either an AU or an individual under the supervision of an AU who has been trained to remove the source applicators in the event of an emergency involving the unit to be immediately available during the continuation of all patient treatments involving the unit.

b. For high dose-rate remote afterloader units, require:

(1) An AU and an AMP to be physically present during the initiation of all patient treatments involving the unit; and

(2) An AMP and either an AU or a physician under the supervision of an AU who has been trained in the operation and emergency response for the unit to be physically present during continuation of all patient treatments involving the unit.

c. For gamma stereotactic radiosurgery units, require an AU and an AMP to be physically present throughout all patient treatments involving the unit.

d. Notify the RSO, or his designee, and the authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

7. Licensees shall have applicable emergency response equipment available near each treatment room to respond to a source that:

a. Remains in the unshielded position; or

b. Lodges within the patient following completion of the treatment.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2044. Dosimetry equipment.

A. Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, licensees shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions shall be met.

1. The system shall have been calibrated using a system or source traceable to the National Institute of Standards and Technology (NIST) and published protocols accepted by nationally recognized bodies or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration shall have been performed within the previous two years and after any servicing that may have affected system calibration; or

2. The system shall have been calibrated within the previous four years. 18 to 30 months after that calibration, the system shall have been intercompared with another dosimetry system that was calibrated within the past 24 months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison shall indicate that the calibration factor of the licensee's system had not changed by more than 2.0%. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

B. Licensees shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with subsection A of this section. This comparison shall have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in subsection A of this section.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2045. Full calibration measurements.

A. Teletherapy units.

1. Licensees authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5.0% from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and

(3) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

c. At intervals not exceeding one year.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include determination of:

a. The output within plus or minus 3.0% for the range of field sizes and for the distance or range of distances used for medical use;

b. The coincidence of the radiation field and the field indicated by the light beam localizing device;

c. The uniformity of the radiation field and its dependence on the orientation of the useful beam;

d. Timer accuracy and linearity over the range of use;

e. On-off error; and

f. The accuracy of all distance measuring and localization devices in medical use.

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subdivision 2 a of this subsection may be made using a dosimetry system that indicates relative dose rates.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection for physical decay for intervals not exceeding one month for cobalt-60, six months for cesium-137, or at intervals consistent with 1.0% decay for all other nuclides.

6. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 5 of this subsection shall be performed by the authorized medical physicist (AMP).

B. Remote afterloader units.

1. Licensees authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

(2) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly;

c. At intervals not exceeding one quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days; and

d. At intervals not exceeding one year for low dose-rate remote afterloader units.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include, as applicable, determination of:

a. The output within plus or minus 5.0%;

b. Source positioning accuracy to within plus or minus 1 millimeter;

c. Source retraction with backup battery upon power failure;

d. Length of the source transfer tubes;

e. Timer accuracy and linearity over the typical range of use;

f. Length of the applicators; and

g. Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. In addition to the requirements for full calibrations for low dose-rate remote afterloader units in subdivision 2 of this subsection, licensees shall perform an autoradiograph of the sources to verify inventory and source arrangement at intervals not exceeding one calendar quarter.

6. For low dose-rate remote afterloader units, licensees may use measurements provided by the source manufacturer that are made in accordance with subdivisions 1 through 5 of this subsection.

7. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection for physical decay at intervals consistent with 1.0% physical decay.

8. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 7 of this subsection shall be performed by the AMP.

C. Gamma stereotactic radiosurgery units.

1. Licensees authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

a. Before the first medical use of the unit;

b. Before medical use under the following conditions:

(1) Whenever spot-check measurements indicate that the output differs by more than 5.0% from the output obtained at the last full calibration corrected mathematically for radioactive decay;

(2) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

(3) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

c. At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

2. To satisfy the requirement of subdivision 1 of this subsection, full calibration measurements shall include determination of:

a. The output within plus or minus 3.0%;

b. Relative helmet factors;

c. Isocenter coincidence;

d. Timer accuracy and linearity over the range of use;

e. On-off error;

f. Trunnion centricity;

g. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

h. Helmet microswitches;

i. Emergency timing circuits; and

j. Stereotactic frames and localizing devices (trunnions).

3. Licensees shall use the dosimetry system described in 12VAC5-481-2044 to measure the output for one set of exposure conditions. The remaining radiation measurements required in subdivision 2 a of this subsection may be made using a dosimetry system that indicates relative dose rates.

4. Licensees shall make full calibration measurements required by subdivision 1 of this subsection in accordance with published protocols accepted by nationally recognized bodies.

5. Licensees shall mathematically correct the outputs determined in subdivision 2 a of this subsection at intervals not exceeding one month for cobalt-60 and at intervals consistent with 1.0% physical decay for all other radionuclides.

6. Full calibration measurements required by subdivision 1 of this subsection and physical decay corrections required by subdivision 5 of this subsection shall be performed by the AMP.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2046. Periodic spot-checks.

A. Periodic spot-checks for teletherapy units.

1. Licensees authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

a. Timer accuracy and timer linearity over the range of use;

b. On-off error;

c. The coincidence of the radiation field and the field indicated by the light beam localizing device;

d. The accuracy of all distance measuring and localization devices used for medical use;

e. The output for one typical set of operating conditions measured with the dosimetry system described in 12VAC5-481-2044; and

f. The difference between the measurement made in subdivision 1 e of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e. the value obtained at last full calibration corrected mathematically for physical decay).

2. Licensees shall perform measurements required by subdivision 1 of this subsection in accordance with written procedures established by the authorized medical physicist (AMP). That individual need not actually perform the spot-check measurements.

3. Licensees shall have the AMP review the results of each spot-check within 15 days. The shall notify the licensee as soon as possible in writing of the results of each spot-check.

4. Licensees authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:

a. Electrical interlocks at each teletherapy room entrance;

b. Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam on-off mechanism);

c. Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

d. Viewing and intercom systems;

e. Treatment room doors from inside and outside the treatment room; and

f. Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

5. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

B. Periodic spot-checks for remote afterloader units.

1. Licensees authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

a. Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;

b. Before each patient treatment with a low dose-rate remote afterloader unit; and

c. After each source installation.

2. Licensees shall perform the measurements required by subdivision 1 of this subsection in accordance with written procedures established by the AMP. That individual need not actually perform the spot-check measurements.

3. Licensees shall have the authorized medical physicist review the results of each spot-check within 15 days. The AMP shall notify the licensee as soon as possible in writing of the results of each spot-check.

4. To satisfy the requirements of subdivision 1 of this subsection, spot-checks shall, at a minimum, assure proper operation of:

a. Electrical interlocks at each remote afterloader unit room entrance;

b. Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

c. Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

d. Emergency response equipment;

e. Radiation monitors used to indicate the source position;

f. Timer accuracy;

g. Clock (date and time) in the unit's computer; and

h. Decayed sources activity in the unit's computer.

5. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

C. Periodic spot-checks for gamma stereotactic radiosurgery units.

1. Licensees authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

a. Monthly;

b. Before the first use of the unit on a given day; and

c. After each source installation.

2. Licensees shall:

a. Perform the measurements required by subdivision 1 of this subsection in accordance with written procedures established by the AMP. That individual need not actually perform the spot-check measurements.

b. Have the AMP review the results of each spot-check within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

3. To satisfy the requirements of subdivision 1 a of this subsection, spot-checks shall, at a minimum:

a. Assure proper operation of:

(1) Treatment table retraction mechanisms, using backup battery power or hydraulic backups with the unit off;

(2) Helmet microswitches;

(3) Emergency timing circuits; and

(4) Stereotactic frames and localizing devices (trunnions).

b. Determine the following:

(1) The output for one typical set of operating conditions measured with the dosimetry system described in 12VAC5-481-2044;

(2) The difference between the measurement made in subdivision 3 b (1) of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

(3) Source output against computer calculation;

(4) Timer accuracy and linearity over the range of use;

(5) On-off error; and

(6) Trunnion centricity.

4. To satisfy the requirements of subdivisions 1 b and 1 c of this subsection, spot-checks shall assure proper operation of:

a. Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

b. Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

c. Viewing and intercom systems;

d. Timer termination;

e. Radiation monitors used to indicate room exposures; and

f. Emergency off buttons.

5. A licensee shall arrange for the repair of any system identified in subdivision 3 of this subsection that is not operating properly as soon as possible.

6. If the results of the checks required in subdivision 4 of this subsection indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2047. Additional technical requirements for mobile remote afterloader units.

A. Licensees providing mobile remote afterloader service shall:

1. Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

2. Account for all sources before departure from a client's address of use.

B. In addition to the periodic spot-checks required by 12VAC5-481-2046, licensees authorized to use a mobile remote afterloader for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks shall be made to verify the operation of:

1. Electrical interlocks on treatment area access points;

2. Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

3. Viewing and intercom systems;

4. Applicators, source transfer tubes, and transfer tube-applicator interfaces;

5. Radiation monitors used to indicate room exposures;

6. Source positioning (accuracy); and

7. Radiation monitors used to indicate whether the source has returned to a safe shielded position.

C. In addition to the requirements for checks in subsection B of this section, licensees shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

D. If the results of the checks required in subsection B of this section indicate the malfunction of any system, licensees shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

12VAC5-481-2048. Full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

A. Licensees shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during each source replacement to assure proper functioning of the source exposure mechanism and other safety components. The interval between each full-inspection servicing shall not exceed five years for each teletherapy unit and shall not exceed seven years for each gamma stereotactic radiosurgery unit.

B. This inspection and servicing may only be performed by person specifically licensed to do so by the agency, the NRC, or another Agreement state.

C. Licensees shall keep a record of the inspection and servicing in accordance with 12VAC5-481-2070 X.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022.

12VAC5-481-2049. Therapy-related computer systems.

Licensees shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of:

1. The source-specific input parameters required by the dose calculation algorithm;

2. The accuracy of dose, dwell time, and treatment time calculations at representative points;

3. The accuracy of isodose plots and graphic displays;

4. The accuracy of the software used to determine sealed source positions from radiographic images; and

5. The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.

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